BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVIAN

    MDR report key: 3052771 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05716
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 23, 2012
    Report Date
    February 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROGRAMMING CHANGES WERE UNSUCCESSFUL. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD BEEN PROGRAMMED TO V-TACHY MODE SET TO VALUE OTHER THAN MONITOR + THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155598 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H229

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR H135| 0184| 4518| 1291| 4087| 4086| H229